D-0434-2023 Class II Terminated
FDA drug recall D-0434-2023 was initiated by B. Braun Medical Inc on March 1, 2023 and is designated Class II. Reason for recall: Subpotent Drug: low Anti-Factor IIa potency. The recall status is terminated (terminated March 13, 2024). Affected quantity: 30672.
Recall Details
- Product Type
- Drugs
- Report Date
- March 15, 2023
- Initiation Date
- March 1, 2023
- Termination Date
- March 13, 2024
- Voluntary/Mandated
- Product Quantity
- 30672
Product Description
Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun Medical Inc, Bethlehem, PA. 18018-3524 USA. NDC 0264-9587-20.
Reason for Recall
Subpotent Drug: low Anti-Factor IIa potency.
Distribution Pattern
Nationwide in the USA
Code Information
Lot J2C017; Expiration: 9/30/2023.